NCT02495285

Brief Summary

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. So far, there is only few data on the safety and efficacy of the products under investigation in children. The primary aim of this non-interventional observational study (NIS) is to collect further data of gelatine solutions in a large pediatric population during routine clinical practice.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

October 1, 2024

Enrollment Period

5 years

First QC Date

June 12, 2015

Results QC Date

February 9, 2023

Last Update Submit

October 15, 2024

Conditions

Treatment of Hypovolemia and Shock

Keywords

pediatric patients gelatine

Outcome Measures

Primary Outcomes (1)

  • Dosing of the Products During Surgery

    Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary Outcomes (11)

  • Potentia Hydrogenii

    Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  • Hemoglobin

    Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  • Lactate

    Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  • Hematocrit

    Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  • Glucose

    Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  • +6 more secondary outcomes

Study Arms (2)

Gelofusine 4%

Children age ≤ 12 years

Drug: Gelofusine 4%

Gelaspan 4%

Children age ≤ 12 years

Drug: Gelaspan 4%

Interventions

Gelofusine 4%DRUG
Gelofusine 4%
Gelaspan 4%DRUG
Gelaspan 4%

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children

You may qualify if:

  • Age ≤ 12 years
  • American Society of Anesthesiologists (ASA) risk score: ≤ III
  • Peri-operative infusion of gelatine solutions
  • Informed consent and/or data protection declaration signed by parents/legal guardians (according to local requirements)

You may not qualify if:

  • In addition contraindications as outlined in the valid local Summaries of Product Characteristics (SmPCs) have to be considered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

National Cardiology Hospital

Sofia, 1606, Bulgaria

Location

Auf der Bult

Hanover, 30173, Germany

Location

Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin

Hanover, 30625, Germany

Location

Klinik Hallerwiese/Cnopf´sche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinikum Stuttgart, Olgahospital und Frauenklinik

Stuttgart, 70174, Germany

Location

Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele

Catania, I-95100, Italy

Location

Ospedale dei Bambini Vittore Buzzi

Milan, I-20154, Italy

Location

Hospital de Sant Joan de Déu

Barcelona, Spain

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

Hospital Son Espases

Palma de Mallorca, Spain

Location

Alder Hey Children's NHS FT

Liverpool, L12 2AP, United Kingdom

Location

Related Publications (1)

  • Rudolf D, Witt L, Boethig D, Rigterink V, Zander R, Sumpelmann R, Dennhardt N. The impact of modified fluid gelatin 4% in a balanced electrolyte solution on plasma osmolality in children-A noninterventional observational study. Paediatr Anaesth. 2022 Aug;32(8):961-966. doi: 10.1111/pan.14494. Epub 2022 May 31.

    PMID: 35588274DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Manager
Organization
B. Braun Melsungen
studies@bbraun.com
05661/71

Study Officials

  • Robert Sümpelmann, Prof.

    Medizinische Hochschule Hannover (MHH)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

July 13, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

December 4, 2024

Results First Posted

December 4, 2024

Record last verified: 2024-10

Locations

ES(3)GB(1)BU(1)DE(4)IT(2)